New US $1 Billion Fund to Finance Development of Antibiotics

The Biotechnology Innovation Organization has issued a press release announcing the creation of essentially a US $1 billion fund to finance the development (particularly late stage) of antibiotics.  The press release states: 

Today more than 20 leading biopharmaceutical companies announced the creation of an estimated $1 billion fund to help support the pipeline for new antibiotic treatments. The AMR Action Fund was launched as the threat of antimicrobial resistance, or AMR, continues to grow and claim more lives. In response to today’s launch of the fund, BIO issued the following statements celebrating the news:

“Antimicrobial resistance is one of the largest and looming public health threats we face today,” said BIO President and CEO Dr. Michelle McMurry-Heath. “Even as the world’s scientists work tirelessly to fight COVID-19, we must not ease up on our battle against antimicrobial resistance. Just as we’ve seen our industry step up during the pandemic, I applaud these biopharmaceutical leaders and partners for committing to the development of new antibiotics. The AMR Action Fund will provide critical support for the development of new medicines, but it is up to policymakers to enact the long-term changes needed to support healthy, sustainable markets for the future development of new and effective antibiotics.”

“For years, we’ve watched antimicrobial-resistance infections rapidly rise around the world, while the market has slowly shrunk for new medicines to fight them,” said Greg Frank, Director of Infectious Disease Policy at BIO & Director of the Working to Fight AMR campaign. “Today’s new AMR Action Fund will have a tremendous impact on the development of new antimicrobials, but we still need government to implement new policies and incentives so companies can successfully develop, test, and launch new antimicrobial products.”

Biopharmaceutical companies and foundations supporting the fund are:

Almirall, Amgen, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Eisai, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, LEO Pharma, Lundbeck, Menarini, Merck, MSD, Novartis, Novo Nordisk, Novo Nordisk Foundation, Pfizer, Roche, Shionogi, Takeda, Teva, and UCB

For more details on the AMR Action Fund, visit www.AMRActionFund.com.

 To learn more about more BIO’s work to fight antimicrobial resistance, visit WorkingToFightAMR.org.

Another Government Report Tackling Pharmaceutical Pricing in the United States that Takes Aim at Patenting Practices

The State of Minnesota has recently released a 94 page report on drug pricing and access titled, “Report of Minnesota Attorney General’sAdvisory Task Force on Lowering Pharmaceutical Drug Prices.”  The Executive Summary of the very thorough report points to several problems leading to the high cost of pharmaceuticals in the United States and the state of Minnesota, including 1) product hopping; 2) abuse of the patent system, including the creation of patent thickets (with Humira as the example); 3) pharmaceutical benefit manager practices and a lack of transparency with respect to pricing; and 4) pharmaceutical company practices with respect to direct marketing to consumers and price discounts to consumers for selecting brand name drugs.  The report has many recommendations, including the formation of a commission to investigate and deal with pharmaceutical pricing and other issues; importation of four important drugs from a vendor (insulin, epipens, Truvada and Naloxon); create price gouging legislation; “Strengthen Minnesota’s consumer fraud laws;” “Enact a state anti-kick back law;” “Strengthen Minnesota’s antitrust laws;” advocate for change to federal patent and data exclusivity laws; heavily regulate pharmaceutical benefit managers; ensure greater transparency; more utilization of the federal 340B drug pricing program; and improved usage of bulk purchasing.  The report also includes action steps for the various recommendations. The report details the impact of high drug prices on citizens of Minnesota as well as case studies of drug prices that are “excessive.”  

I am sure the issue regarding the cost of healthcare and pharmaceuticals in the United States will receive a lot of attention in U.S. presidential race this year.  Last April, Chris Holman and I co-organized a conference at University of the Pacific, McGeorge School of Law, in Sacramento, California, on pharmaceutical IP and pricing that tackled the issue. The conference website is available, here.  We may offer a follow-up conference next year after the presidential election.  If you have an interest in attending or participating, please let me know.  

Extra Protection for the Bayh-Dole Act Needed in the United States?

Bayh-Dole 40 is a new coalition of supporters of the landmark legislation concerning technology transfer—the Bayh-Dole Act.  The Bayh-Dole 40 has an attractive website with information concerning the history of the Act and its impact.  The press release states: 

Today, a diverse group of research and scientific organizations, as well as those directly involved in commercializing new products, launched Bayh-Dole 40, a coalition that will celebrate and protect the University and Small Business Patent Procedures Act of 1980, better known as the “Bayh-Dole Act.”

The Bayh-Dole Act has empowered universities, small businesses, and nonprofits that have received federal grants to retain ownership of any patented inventions — and license those patents to private firms, who then turn promising ideas into real-life products that improve peoples’ lives. Thanks to Bayh-Dole, the public and private sectors have worked together to translate basic scientific research into life-saving drugs and medical devices, internet and GPS technologies, rechargeable lithium-ion batteries, and countless other innovations.

“Bayh-Dole made the United States the engine of global innovation,” said Bayh-Dole 40 founder and executive director Joseph Allen, who helped enact the law as a member of Senator Birch Bayh’s U.S. Senate Judiciary staff. “The Act reinvigorated research and development in America, spawning breakthrough discoveries ranging from high-yield crops to advanced medicines.”

Thanks to Bayh-Dole, over 200 new therapies — including drugs and vaccines — have been created since 1980. The legislation has also bolstered U.S. economic output by $1.3 trillion, supported 4.2 million jobs, and led to more than 11,000 start-up companies.

Bayh-Dole 40’s founding members include AUTM, Biotechnology Innovation Organization, BioHealth Innovation, Council on Governmental Relations, Information Technology and Innovation Foundation, Licensing Executives Society, and PhRMA, spanning the entire U.S. innovation ecosystem. The coalition will educate lawmakers to ensure the Act is utilized in the way Senators Birch Bayh and Bob Dole envisioned.

“Misusing Bayh-Dole to undermine the existing framework for public-private technology transfer and development, as some lawmakers are suggesting, would jeopardize the future of U.S. life-sciences innovation,” said Stephen Ezell, Vice President of Global Innovation Policy at the Information Technology and Innovation Foundation. “We look forward to engaging Congress on these issues to ensure the United States remains a life-sciences R&D powerhouse.”

About Bayh-Dole 40: Bayh-Dole 40 is a coalition of research and scientific organizations, as well as those directly involved in commercializing new products, dedicated to celebrating and protecting the University and Small Business Patent Procedures Act of 1980, better known as the “Bayh-Dole Act.” The coalition was formed to educate policymakers about Bayh-Dole’s positive impact on medical innovation and defend the Act against imminent threats during its 40th anniversary year.

Bayh-Dole 40’s members include the Association of University Research Parks, AUTM, BIOCOM, BioHealth Innovation, Biotechnology Innovation Organization, California Life Sciences Association (CLSA), Columbia Technology Ventures (CTV), Council on Competitiveness, Council on Governmental Relations, Fuentek, Information Technology and Innovation Foundation, IPWatchdog, Lehigh University Office of Economic Engagement, Licensing Executives Society (LES), Licensing Executives Society (LES) Silicon Valley Chapter, National Venture Capital Association, Pharmaceutical Research and Manufacturers of America, Pristine Surgical, STC.UNM, the IDEA Center at the University of Notre Dame, Wisconsin Alumni Research Foundation, and the Yale Office of Cooperative Research.

It is interesting that the existence of the coalition is necessary to protect the Bayh-Dole Act.  There is some polling to support that U.S. Senator Bernie Sanders could defeat President Trump in an election, but I wonder if anyone really believes that polling (besides Sanders supporters) after the results of the last Presidential election. Maybe the concern will be what happens in the election after this one.